Headset for treatment and assessment of medical conditions

ABSTRACT

A circumferential headset for use in delivering electrical stimulation to the skin surface of the head.

REFERENCE TO RELATED APPLICATION

The present application is a Continuation In Part of PCT ApplicationPublication Number WO2014/141213, filed 15 Mar. 2014 and entitled“HEADSET FOR TREATMENT AND ASSESSMENT OF MEDICAL CONDITIONS”, whichgains priority from U.S. Provisional Application No. 61/786,701 filed on15 Mar. 2013, both of which are hereby incorporated by reference as iffully set forth herein.

FIELD OF THE INVENTION

The present invention relates to apparatus and methods for applyingelectrical stimulation to the head region, to headsets having electrodesfor treatment of medical conditions using non-invasive electricalstimulation, to headsets adapted to assess medical conditions, and toelectrode arrangements for use with such headsets.

SUMMARY OF THE INVENTION

According to some teachings of the present invention there is provided aheadset for use in delivering electrical stimulation to a skin surfaceof a head of a user, the headset including: (a) a circumferentialheadset body, the body having a monolithic frame adapted tocircumferentially fit around the head of the user, the body housing anelectric circuit adapted to be connected to a power source; the headsetbody including an elastic arrangement, disposed on at least a portion ofa circumference of the headset body; the elastic arrangement adapted tobe tensioned along the circumference; (b) at least one electrode base,mechanically and at least semi-rigidly connected to the headset body,and electrically associated with the electric circuit, the electrodebase adapted to receive at least one electrode pad; the headset body andthe base adapted to orient an electrical stimulation surface of the padtowards the skin surface, during donning by the user; the elasticarrangement adapted such that, during the donning, the elasticarrangement radially urges the electrode base towards the skin surfacesuch that the electrode pad makes physical and electrical contact withthe skin surface; the elastic arrangement and the electrode base adaptedsuch that for various degrees of tensioning of the elastic arrangement,a circumferential position of the electrode base, with respect to theframe, is fixed in a unique position.

According to another aspect of the present invention there is providedan electrode pad including: (a) a liquid-absorbent layer having abiocompatible, conductive contact surface, the contact surface adaptedto be juxtaposed against the skin surface; (b) an electricallyconductive layer having a broad first face attached to theliquid-absorbent layer, the conductive layer containing a carbon foil orcarbon film, the conductive layer adapted to transfer an electricalcurrent from a broad second face, distal to the first face, to theliquid-absorbent layer, via the first face, the liquid-absorbent layerand the electrically conductive layer forming an integral structure.

According to yet another aspect of the present invention there isprovided an electrode base having: (a) a housing including a floor, anda flexible circumferential member surrounding the floor, and having aflexible circumferential wall extending generally above a perimeter ofthe floor, the wall ending in a circumferential rim; the floor and theflexible circumferential member forming a cavity adapted to receive anelectrically conductive electrode pad; and (b) an electricallyconductive material, disposed at least partially above, or within, thefloor; the conductive layer adapted to be electrically associated to anelectrical circuit, by means of an electrical conductor, and, when thepad is inserted, to electrically communicate, in an operational mode,with the electrode pad; the rim and the flexible circumferential walladapted such that a pressure exerted against the electrode base,generally perpendicular to the rim, and towards a skin surface of auser, urges the rim against the skin surface, to substantially fluidlyseal between the cavity and an ambient or external environment.

According to yet another aspect of the present invention there isprovided a biocompatible electrode for juxtaposing against a skinsurface of a user, the electrode including: (a) a liquid-absorbent layerhaving a biocompatible contact surface, the contact surface adapted tobe juxtaposed against the skin surface; (b) an electrode backing,attached to the liquid-absorbent layer, the backing containing at leastone electrically conductive material or element, the conductive materialor element being electrically connected, in an operational mode, withthe liquid-absorbent layer, when the liquid-absorbent layer is filledwith liquid; the biocompatible contact surface having: (i) a longdimension (D_(L)) having a maximum length of 20 mm to 55 mm; (ii) anarrow dimension (D_(N)) having a maximum length of 10 mm to 25 mm; afirst side of a perimeter of the biocompatible contact surface having agenerally concave contour having a concavity defined by first and secondboundary points disposed at opposite ends of the concavity, wherein:

A/L≧0.5 mm

A being an area bounded by the line and the concavity;L being a length of a line between the boundary points; the length (L)being at least 10 mm; a line disposed between a first point on theconcave contour and a second point on the perimeter, on a side oppositethe concave contour, and aligned in perpendicular fashion with respectto the contour at the first point, having a length H, and wherein, overan entirety of the concave contour,

H _(max) /H _(min)≦2.5,

H_(max) being a maximum value of H over the entirety; andH_(min) being a minimum value of H over the entirety.

According to yet another aspect of the present invention, there areprovided methods of donning and positioning the headset on the head ofthe user, substantially as described herein.

According to further features in the described preferred embodiments,the circumferential headset body has a front section adapted to fitaround a front portion of the head, and the at least one electrode baseis a front electrode base disposed on the front portion.

According to still further features in the described preferredembodiments, the front section is a front mechanical element that isphysically distinct from the circumferential headset body.

According to still further features in the described preferredembodiments, the front mechanical element spans at most 40%, at most35%, at most 30%, or at most 20%, of a circumference of thecircumferential headset body.

According to still further features in the described preferredembodiments, the front mechanical element spans within a range of 10% to40%, 15% to 40%, 20% to 40%, 25% to 40%, or 25% to 35%, of acircumference of the circumferential headset body.

According to still further features in the described preferredembodiments, the circumferential headset body has a rear section adaptedto fit around a rear portion of the head, and the at least one electrodebase includes a rear electrode base disposed on the rear portion.

According to still further features in the described preferredembodiments, the rear section is a rear mechanical element that isphysically distinct from the circumferential headset body.

According to still further features in the described preferredembodiments, the rear mechanical element spans at most 40%, at most 35%,at most 30%, or at most 20%, of a circumference of the circumferentialheadset body.

According to still further features in the described preferredembodiments, the rear mechanical element spans within a range of 10% to40%, 15% to 40%, 20% to 40%, 25% to 40%, or 25% to 35%, of acircumference of the circumferential headset body.

According to still further features in the described preferredembodiments, the front and rear mechanical elements span, in total, 45%to 75%, 50% to 75%, 55% to 75%, or 55% to 70%, of the circumference.

According to still further features in the described preferredembodiments, the frame includes at least semi-rigid side components,bi-laterally disposed on the frame, and forming side portions of thecircumference of the headset body.

According to still further features in the described preferredembodiments, the side components span, in total, 15% to 50%, 20% to 50%,25% to 50%, 30% to 50%, 35% to 50%, or 30% to 45%, of the circumference.

According to still further features in the described preferredembodiments, each of the side components has an element disposedgenerally perpendicular to the circumference, and adapted, in a donnedmode, to fit behind an ear of the user.

According to still further features in the described preferredembodiments, the circumferential rigidity of the side components exceedsa circumferential rigidity of the front section and the rear section.

According to still further features in the described preferredembodiments, the circumferential elasticity of the front section and therear section exceed a circumferential elasticity of the side components.

According to still further features in the described preferredembodiments, the frame includes a positioning system for angular andlongitudinal positioning of the headset body, the positioning systemincluding at least one at least semi-rigid side component, the sidecomponent having: a first, elongated element, forming a portion of thecircumference, and adapted to fit above an ear of the user, to determinethe longitudinal positioning, and a second element disposed generallyperpendicular to the elongated element, and adapted to fit behind theear, to determine the angular positioning of the headset body.

According to still further features in the described preferredembodiments, the frame includes at least a first bi-lateral sizeadjustment mechanism adapted to fixedly adjust the circumference of theheadset body.

According to still further features in the described preferredembodiments, the adjustment mechanism is rigid or at least semi-rigid.

According to still further features in the described preferredembodiments, the frame includes first and second bi-lateral sizeadjustment mechanisms adapted to adjust the circumference of the headsetbody, the first adjustment mechanism connecting the side components tothe front section, and the second adjustment mechanism connecting theside components to the rear section.

According to still further features in the described preferredembodiments, the first and second adjustment mechanisms are adapted toenable adjustment of the circumference of the headset body while acircumferential position of the side components remains fixed.

According to still further features in the described preferredembodiments, the frame is adapted such that along at least 30%, at least40%, at least 50%, or at least 60% of a length of the circumference, theframe is substantially non-elastic.

According to still further features in the described preferredembodiments, the headset body is adapted to juxtapose a contact surfaceof an electrical device opposite or against the skin surface, theelastic arrangement adapted to radially urge the electrical devicetowards the skin surface such that a contact surface of the electricaldevice makes physical contact with the skin surface; the elasticarrangement adapted such that for various degrees of tensioning of theelastic arrangement, a circumferential position of the electrical deviceis fixed in a unique position.

According to still further features in the described preferredembodiments, the electrical device includes a sensor adapted to sense abody parameter associated with the head of the user.

According to still further features in the described preferredembodiments, the liquid-absorbent layer of the electrode pad includes atleast one material selected from the group consisting of a non-wovenfabric, felt or sponge.

According to still further features in the described preferredembodiments, the electrically conductive layer has, on a second face,distal to the liquid-absorbent layer, an electrically conductive layerhaving a higher electrical conductivity than the bulk of theelectrically conductive layer, this highly conductive layer typicallybeing an electrically conductive paint, preferably disposed in a meshpattern.

According to still further features in the described preferredembodiments, the liquid-absorbent layer and the electrically conductivelayer having the layer of electrically conductive paint form an integralstructure.

According to still further features in the described preferredembodiments, the conductive carbon film or carbon foil has a resistivityof 1-180 ohm/square or 30-100 ohm/square.

According to still further features in the described preferredembodiments, the conductive carbon film or carbon foil has a thicknesswithin a range of 30-1500 microns or 50-200 microns.

According to still further features in the described preferredembodiments, on the rim of the electrode base are circumferentiallydisposed a plurality of sealing fingers containing a volume, the sealingfingers adapted such that, when the rim is urged against the skinsurface, the plurality of sealing fingers substantially seal between thevolume and a volume external to the sealing fingers.

According to still further features in the described preferredembodiments, the rim includes, or consists essentially of, acircumferentially disposed plurality of sealing fingers, the sealingfingers adapted such that, when pressure is exerted, in generallyperpendicular fashion with respect to the electrode base floor, or tothe skin surface, the plurality of sealing fingers substantially sealbetween the cavity and a volume external to the rim.

According to still further features in the described preferredembodiments, the ratio A/L of the electrode arrangement is at least 0.2mm, at least 0.5 mm, at least 0.7 mm, at least 1 mm, at least 1.5 mm, orat least 1.7 mm.

According to still further features in the described preferredembodiments, the length (L) is at least 12 mm, at least 15 mm, at least18 mm, or at least 20 mm.

According to still further features in the described preferredembodiments, the electrode arrangement further includes an electrodepad.

According to still further features in the described preferredembodiments, an inner surface of the flexible circumferential wall has aradial curvature, and a radial distance between an inner surface of therim, and a most radially inward point of the inner surface of the wall,is at least 1 mm, at least 3 mm, at least 5 mm, or at least 10 mm.

According to still further features in the described preferredembodiments, this radial distance is within a range of 1 to 15 mm, 2 mmto 12 mm, 2 mm to 10 mm or 2 mm to 7 mm.

According to still further features in the described preferredembodiments, an outer surface of the flexible circumferential wall has aradial curvature, and wherein a length of the curvature of the outersurface is at least 1 mm, at least 2 mm, at least 3 mm or at least 5 mm.

According to still further features in the described preferredembodiments, a length of the curvature of this outer surface is within arange of 1 mm to 15 mm, 2 mm to 10 mm or 3 mm to 8 mm.

According to still further features in the described preferredembodiments, the electrode arrangement further includes a pressuringarrangement, mechanically associated with the electrode base, andadapted to deliver the pressure against the electrode base, generallyperpendicular to the rim.

According to still further features in the described preferredembodiments, the electrical device includes a transmitting arrangementadapted to transmit a signal from the sensor.

According to still further features in the described preferredembodiments, the electrode base housing includes a flexible bellows-typemember.

According to still further features in the described preferredembodiments, the electrode base housing includes a liquid trapping andstoring arrangement.

BRIEF DESCRIPTION OF THE FIGURES

The invention is herein described, by way of example only, withreference to the accompanying drawings. With specific reference now tothe drawings in detail, it is stressed that the particulars shown are byway of example and for purposes of illustrative discussion of thepreferred embodiments of the present invention only, and are presentedin the cause of providing what is believed to be the most useful andreadily understood description of the principles and conceptual aspectsof the invention. In this regard, no attempt is made to show structuraldetails of the invention in more detail than is necessary for afundamental understanding of the invention, the description taken withthe drawings making apparent to those skilled in the art how the severalforms of the invention may be embodied in practice. Throughout thedrawings, like-referenced characters are used to designate likefunctionalities, but not necessarily identical elements.

In the drawings:

FIGS. 1 and 1A provide perspective views of one embodiment of theinventive headset, positioned on a head of a user;

FIG. 2 is a perspective view of one embodiment of the inventive headset;

FIGS. 3 and 4 respectively provide a side view of inventive headsets,positioned on a head of a user;

FIG. 5 is a side view of a portion of an inventive headset having abifurcated posterior elastic member for improved headset stability;

FIG. 6 is a perspective view of an inventive headset having a posteriorelastic member devoid of electrodes;

FIGS. 7 and 7A provide perspective views of an inventive electrode basearrangement, and an elastic member for housing this arrangement,according to one embodiment of the present invention;

FIG. 8 provides a perspective view of an inventive electrode basearrangement, according to a particular embodiment of the presentinvention;

FIG. 8A provides a perspective view of the elastic member shown in FIG.7A with a cross section at a middle portion thereof;

FIG. 9 is a cross-sectional view of the electrode base of FIG. 7,coupled inside the elastic member of FIG. 7A;

FIG. 10 provides a perspective view of the inventive structure shown inFIG. 9;

FIGS. 11A-11C illustrate an inventive, adjustable electrode basearrangement for adjusting the distance between adjacent electrode basehousings, and three different positionings of those electrode basehousings;

FIG. 11D provides a perspective view of an elastic member for housingthe adjustable electrode base arrangement shown in FIGS. 11A-11C;

FIGS. 12 and 13 illustrate an adjustable electrode base housingarrangement, and an elastic member for housing this arrangement,according to one embodiment of the present invention;

FIG. 14 is a cross-sectional view of an electrode pad disposed anelectrode base;

FIGS. 15A and 15B provide perspective views of an electrode base with(FIG. 15A) and without (FIG. 15B) a multi-layered electrode pad,according to the present invention;

FIG. 15C and FIG. 15D provide cross-sectional and bottom views of thismulti-layered electrode pad;

FIGS. 16A, 17A, 18A, 19A, and 20A provide cross-sectional views of anelectrode base assembly, in which a particular electrode pad structureis coupled to an electrode base housing, according to variousembodiments of the present invention;

FIGS. 16B, 17B, 18B, 19B, and 20B provide cross-sectional views of eachrespective electrode pad shown in FIGS. 16A, 17A, 18A, 19A, and 20A;

FIG. 21 provides a perspective view of a spring-mounted electrode basehousing containing an electrode pad;

FIGS. 21A and 21B provide perspective and cross-sectional views,respectively of an electrode pad and bellows-type electrode basehousing, according to an embodiment of the present invention;

FIGS. 21C and 21D provide perspective and cross-sectional views,respectively of an electrode pad and collapsing electrode base housing,according to an embodiment of the present invention;

FIG. 22 is a perspective view of an inventive electrode base housinghaving a circumferential sealing rim;

FIG. 23 provides a cross-sectional view of the electrode base housingshown in FIG. 22, the housing having an electrode pad disposed therein;

FIG. 24 provides a cross-sectional view of the electrode base housingand electrode pad shown in FIG. 22, the electrode pad being urgedagainst a skin surface;

FIG. 25 is a cross-sectional view of an electrode base in which the wallgeometry is defined;

FIG. 25A provides a cross-sectional view of an inventive electrode basehousing containing an electrode pad, the electrode pad being urgedagainst a skin surface;

FIG. 25B provides a cross-sectional view of the housing and padarrangement of FIG. 25A in a relaxed mode, and in which the wallgeometry is defined;

FIG. 25C provides a perspective view of an inventive electrode basehousing containing an electrode pad, the housing containing a pluralityof closely spaced sealing fingers circumferentially enveloping theelectrode pad;

FIG. 25D provides a cross-sectional view of the housing and padarrangement of FIG. 25C;

FIG. 25E provides a top view of the housing and pad arrangement of FIG.25C;

FIG. 25F provides a cross-sectional view of an inventive housing and padarrangement in which the housing wall curvature is adapted to trapexcess fluid;

FIG. 25G provides a schematic perspective cross-sectional view of oneembodiment of the inventive headset, positioned on a head of a user, andFIG. 25H provides magnified views of the electrode base housings urgedagainst the head;

FIG. 26 is a perspective view of a flexible, comb-like member disposedabove an electrode base housing, according to embodiments of theinvention;

FIG. 27 is a perspective rear view of a donned headset in which theflexible, comb-like member of FIG. 26 protrudes above thecircumferential band of the headset;

FIG. 28 is a perspective anterior view of a donned headset, the headsetconfigured, and the front electrodes adapted and positioned to stimulatespecific nerve branches in the forehead region, according to embodimentsof the invention;

FIG. 29 provides the dimensions of an inventive electrode configured toselectively stimulate nerve branches in the supraorbital region;

FIG. 30 is a perspective rear view of a donned headset, the headsetconfigured, and the rear electrodes adapted and positioned to stimulatespecific nerve branches in the occipital nerve region, according toembodiments of the invention;

FIG. 31 provides a side perspective view of a bilateral member of aninventive headset, according to one embodiment of the invention;

FIG. 32 is a perspective view of a donned, inventive headset;

FIG. 33 is a perspective anterior view of a donned, inventive headsethaving a nose bridge support member;

FIG. 34 is a perspective view of a donned, inventive headset havingassociated eyeglasses;

FIG. 35 is a perspective view of an inventive headset having associatedearphones; and

FIG. 36 provides a perspective view of a donned, inventive headsetadapted to communicate with a remote control unit, mobile phone, andcomputer

DETAILED DESCRIPTION

Device and methods are described herein that include a headset with oneor more integrated electrodes for applying electrical stimulation toperipheral nerves, cranial nerves and brain regions. The inventiveheadset is a head mounted construction that can be served as a platformfor applying electrical stimulation to treat various conditions such asmigraine and tension headaches, fibromyalgia, depression, post-traumaticstress syndrome, anxiety, obsessive compulsive disorder (OCD), insomnia,epilepsy, attention deficit hyperactivity disorder (ADHD), Parkinson'sdisease, Alzheimer's disease, multiple sclerosis, and stroke. Theinventive headset may facilitate motor and cognitive learning and mayinduce relaxation. The inventive headset may also serve as a platformfor various sensors, in order to detect and/or assess variousconditions.

The stimulation electrodes and the quality of its contact with the scalpare a fundamental aspect in the functionality of the invented apparatus.Ensuring optimal conductivity between the electrodes and the scalp isessential for proper transfer of the electrical current to the targettissues, which is the basis for an effective treatment. Improperconductivity may result in failure of the therapy, unpleasant sensationand even skin irritation due to “hot spots” of high current density. Theinventors have also found that non-invasive application of electricalcurrent to the head region, no matter which indication it is appliedfor, may pose numerous challenges including stimulation in the presenceof hair, high level of sensory sensitivity of the scalp and forehead,the criticality of robust contact and electrical conductivity betweenthe electrodes and the scalp, despite variations in head size andcontours, and accurate placement of the stimulating electrodes above thetarget nerve and brain regions.

Several aspects of the present invention relate to features that areaimed at ensuring that the electrical current is properly delivered fromthe electrode to the target tissues and for treating and assessing thehead region in an effective and comfortable manner.

With reference now to the drawings, FIG. 1 and FIG. 1A provideperspective views of one embodiment of the invented headset system 10,donned on head 5. In one embodiment, headset 10 may be configured toinclude a circumferential frame (“headset body”) that may include aposterior elastic member 30, an anterior elastic member 40 and bilateralsemi rigid and preferably rigid members 50 a. Posterior elastic member30 may be configured to be coupled to bilateral members 50 a atconnection point 8 and 16. Anterior member 40 may be configured to becoupled to bilateral members 50 a at connection points 14 and 18.Anterior member 40 may be configured to encompass the forehead region12. Posterior elastic member 30 may be configured to encompass theocciput region 11. Middle bilateral semi-rigid members 50 a nay beconfigured to be positioned behind and above ears 16.

FIG. 2 illustrates a perspective view of one embodiment of the inventedheadset system 10. Headset 10 may be configured to include an elasticposterior member 30, elastic anterior member 40 and rigid and preferablysemi-rigid bilateral members 50 a. Posterior member 30 may be configuredto connect to middle bilateral members 50 a by size adjustmentmechanisms 32 a and 32 b, configured to be located behind the ears.Anterior member 40 may be configured to connect to bilateral middlemembers 50 a by size adjustment mechanisms 42 a and 42 b, configured tobe located at both sides of the head, anterior to the ears.

The adjustment of headset 10 to various head sizes may be performed bybilateral anterior adjustment mechanisms 32 a and 32 b and posteriorbilateral adjustment mechanisms 42 a and 42 b. Pulling or pushingelastic members 30 and 40 away from or toward middle bilateral members50 a, allows increasing or decreasing the size/circumference of headset10. According to certain embodiment, middle bilateral members 50 a maybe configured to be flexible in order to self-align to a wide variety ofhead contours.

The mechanism for adjustment of headset 10 to various head sizes mayinclude solely bilateral anterior adjustment mechanisms 32 a and 32 b,or bilateral posterior adjustment mechanisms 42 a and 42 b.

In some embodiments, having both anterior adjustment mechanisms 32 a and32 b and posterior adjustment mechanisms 42 a and 42 b may enable betteradjustment of the headset while maintaining its symmetrical placement onthe head. Furthermore, it may enable adjustment of the headset sizewhile maintaining the proper placement of bilateral members 50 a behindthe corresponding ears.

Posterior member 30 and anterior member 40 may be configured to containelectrode bases (also called electrode system) 60 and 70 respectivelyand when stretched, are configured to apply radial force on electrodebase housing 150 toward the scalp in order to ensure electrical couplingbetween electrodes pads 56 a and the skin surface, while minimizingundesired pressure of the headset against the scalp at areas that doesnot hold the electrodes.

Middle bilateral member 50 a may be configured to contain electroniccircuit 52 b, which may be configured to be electrically coupled byconductive wires 54 to battery 52 a and to electrodes units 60 and 70.

Electronic circuit 56 b may be configured to include a stimulationcircuit, a microprocessor, a charging circuit and a user interface.

The stimulation circuit may be configured to produce biphasic, chargedbalanced electrical pulses, mono-phasic electrical pulses, and/or directcurrent stimulation.

According to still further features of the described preferredembodiments, the stimulation circuit may be configured to produceelectrical stimulation within an intensity range of 0-80 mA, 0-40 mA,0-20 m, or 0-15 mA.

According to still further features of the described preferredembodiments, the stimulation circuit may be configured to producestimulation pulses with a duration of 10-600 μsec, 50-500 μsec, 100-500μsec, 100-450 μsec, 150-400 μsec or 150-450 μsec.

According to still further features of the described preferredembodiments, the stimulation circuit may be configured to producestimulation pulses at a frequency of 1-500 Hz, 10-300 Hz, 10-250 Hz,20-180 Hz or 30-180 Hz.

According to still further features of the described preferredembodiments, headset 10 may be configured to connect to an externalelectronic and stimulation circuit and thereby to transfer electricalcurrent from the external stimulator to the headset electrodes. Headset10 may be configured to connect to at least one external electrode thatmay be located at various areas of the body. Headset 10 may beconfigured to connect to an external electronic circuit and processor inorder to transfer signals from its on board sensors to the externalprocessor.

Battery 52 a may be recharged by plugging a charger to charging port 770located on member 50 a. Bilateral member 50 a may also be configured toinclude user controls and interface 750. In some embodiments, bothbilateral members may be configured to include a user interface 750. Insome embodiments, other parts of inventive headset 10, such as anteriormember 40 or posterior member 30, may be configured to include userinterface 750.

In some embodiments of the present invention, elastic members 30 and 40of headset 10 may be configured, in a stretched mode, to transfer radialforce to electrode base housing 150 in order to ensure contact betweenelectrode pads 56 a and the skin surface, while minimizing undesiredpressure of the headset against the scalp at areas that does not holdthe electrodes.

FIG. 3 is an illustration of a side view of headset 10. In someembodiments, headset 10 may be configured to be positioned at a higherlocation on the head while maintaining its various properties includingaccurate placement, adjustment to various head sizes and electrodeattachment. Positioning headset 10 at a higher location on the head mayenable stimulation of other nerves and brain regions, and may alsoenable positioning of various sensors, such as for example EEG sensors,at higher locations over the head.

According to another aspect of the present invention, headset 10 may beconfigured to include wider elastic members 40 and 30, with bilateralmember 56 a that may be adapted to connect to wider members 40 and 30.Wider members 40 and 30 may enable integration of larger electrodeswithin headset 10 in order to stimulate larger areas, such as forstimulation of various brain regions.

FIG. 4 provides a side view of headset 10, having additional semi-rigidand preferably elastic member 590, configured to be coupledperpendicularly to bilateral member 56 a and adapted to be disposedbetween bilateral members 56 a and to encompass the top of the head.Elastic member 590 may enable stimulation and positioning of electrodesand sensors at higher locations on the head.

FIG. 5 provides a side view of headset 10, configured to include abifurcated posterior elastic member 30 in order to increase thestability of headset 10 over the occiput region.

FIG. 6 is a perspective view of headset 10, where posterior elasticmember 30 does not hold electrodes and its main or sole function is tostabilize headset 10 on the head.

When required, anterior elastic member 40 may be configured to notinclude electrodes while posterior member 30 includes the electrodes.

FIG. 7 provides a perspective view of an inventive electrode base orbase arrangement 60; FIG. 7A provides a perspective view of an elasticmember 30 for housing arrangement 60, according to one embodiment of thepresent invention.

With reference to FIGS. 7 and 7A, elastic member 30 is configured to beat least partially hollow in order to contain electrode base 60 andelectrical conducting wires 54, as well as to assist in preserving astable three-dimensional configuration of the headset while maintaininga low modulus of elasticity. Elastic member 30 may be configured toinclude at least one opening 82 on an interior side (facing the skinsurface). Electrode base 60 may be configured to include at least onehousing 150. In one embodiment, housing 150 is configured to be coupledto elongated flexible member 64. Electrode base 60 may be configured tobe physically coupled inside elastic member 30, such that a flexibleconnecting band 84 is coupled to elastic member 30 at coupling portion64.

Elastic member 30 may have a lower modulus of elasticity above electrodebase housing 150, compared to a higher modulus of elasticity in itsother areas. A lower modulus may be achieved in areas of member 30 thatare parallel to the bottom surface of housing 150, due to opening 82and, for example, due to configuring the external surface of member 30,in the area parallel to openings 82, to be thinner than its other areas.Thus, when headset 10 is donned, a focal radial force is applied bymember 30 on electrode base housing 150 toward the scalp. In contrast,other areas of elastic member 30 may be configured to have a highermodulus of elasticity and therefore the radial force toward the scalp atthese areas is minimized in order to prevent excess pressure where notneeded. The areas which are configured to have a higher modulus ofelasticity may also assist in maintaining a stable three-dimensionalstructure of member 30 and of headset 10, thereby facilitating easierdonning and accurate placement of the electrodes.

FIG. 8 and FIG. 8A provide a perspective view of electrode base 60 and across-sectional view of elastic member 30 (shown in FIG. 7A),respectively. In order to enable coupling to electrode base 60, elasticmember 30 may be configured to include protrusions 96 a and 96 b.Electrode base 60 may be configured to include holes 98 a and 98 b inflexible connecting band 84. In order to physically couple electrodebase 60 and elastic member 30, electrode base 60 may be inserted intoelastic member 30, such that protrusions 96 a and 96 b may be snappedinto holes 98 a and 98 b. The physical coupling may include othermechanisms. For example, flexible member 68 may be glued at its couplingportion 64 to flexible member 30.

FIG. 9 provides a cross-sectional view of electrode base 60, coupledinside elastic member 30. Electrode base 60 may be integrated insideheadset member 30 where flexible connecting band 84 may be physicallycoupled to elastic member 30 at coupling portion 64 only, and therefore,when the headset is donned, member 30 may be stretched to elicit radialforce on electrode base housing 150 and electrode pads 56 a toward thescalp, without being constrained by electrode system 60. Thisarrangement also ensures that when headset member 30 is stretched, thepre-determined distance between electrode base housing 150 ismaintained.

FIG. 10 illustrates a portion of headset member 30 according to oneembodiment. Electrode system 60 (partially hidden) is integrated insidemember 30 while only electrode base housing 150 and electrode pads 56 aprotrude through openings 82 a and 82 b of elastic member 30. Flexibleconnecting band 84 and coupling portion 64 are illustrated by dottedlines. Openings 82 a and 82 b may extend beyond the medial edge ofelectrode base housings 150 in order to allow openings 82 a and 82 b toextend laterally when member 30 is stretched and therefore the extensionof member 30 may not be constrained.

FIGS. 11A-11C are perspective views of an inventive electrode basearrangement in which the distance between adjacent electrode basehousings 150, may be pre-set. FIGS. 11A-11C provide three differentpre-set positionings 60A-60C of those electrode base housings. FIG. 11Dprovides a perspective view of an elastic member for housing theadjustable electrode base arrangement shown in FIGS. 11A-11C.

According to certain features of the described preferred embodiments,the position of electrode base housing 150 may be adjusted to fitvarious morphological and anthropometric variables of certain users.According to one embodiment, electrode base units 60 a, 60 b and 60 cmay be configured to have a variable distance between its electrode basehousing 150. It may be configured to be reversibly coupled to elasticmember 30 by holes 64 of the electrode system and protrusions 96 a and96 b (both hidden) on elastic member 30. According to certain featuresof the described preferred embodiments, coupling of electrode base units60 a, 60 b and 60 c may also be performed by other coupling mechanisms.

FIG. 12 and FIG. 13 illustrate a mechanism for adjustment of theplacement of electrode base housing 150 according to further features ofthe described preferred embodiment.

FIG. 12 illustrates an interior view of elastic member 30 according toone embodiment, where flexible connecting band 84 is coupled to member30 by protrusions 96 a and 96 b (both hidden) elongating from member 30and snaped into holes in flexible connecting band 84. The mechanicalcoupling of flexible connecting band 84 and elastic member 30 may beperformed by other mechanisms such as other snap connectors or bygluing. According to one embodiment, flexible connecting band 84 isconfigured to include holes 98 at a distance within a range of 0.5-5 cmbetween each hole, and more typically, within 0.5-3 cm, 0.5-2 cm, or0.5-1 cm.

FIG. 13 illustrates a bottom view of a portion of electrode base 60.According to one embodiment, electrode base housing 150 may beconfigured to include protrusions 92 a and 92 b arising from its bottomsurface. Protrusions 92 a and 92 b are configured to be snaped into anyof the holes 98 in flexible connecting band 84. The placement ofelectrode base housing 60 may be adjusted by snapping protrusions 92 aand 92 b into other holes 98 in flexible connecting band 84.

FIG. 14 is a cross section of an electrode pad 56 a disposed in anelectrode base 60. Electrode base 60 may be configured to be physicallycoupled to the headset by elongated flexible connecting band 84 and maybe electrically coupled to the headset electrical circuit by conductivewire 158. It may be configured to include at least one electrode basehousing 150 which include elevated circumferential walls that aresurrounding a “floor”, thereby creating a cavity adapted to receive atleast one conductive electrode pad 56 a. According to certainembodiment, electrode base housing 150 is preferably made of a flexiblematerial such as silicon or thermoplastic polyurethane (TPU).

Electrode base housing 150 may be configured to include an electricallyconductive material 154 disposed at least partially above, or withinelectrode base housing 150 floor. The conductive layer is adapted to beelectrically coupled to an electric circuit by electrical conductor 158.

Conductive layer 154 may be configured to include material such asstainless steel, copper, brass, silicone carbon, conductive silver paintprint, stainless mesh or other conducting elements. When conductivelayer 154 is made of carbon, an additional layer of conductive paint maybe printed on its bottom surface. Such a conductive paint layer mayimprove the homogeneity of current distribution across the surface ofconductive layer 154 and thereby improve the homogeneity of currentdistribution on the surface of electrode pad 56 a. Conductive layer 154may preferably be flexible in order to not compromise the overallflexibility of electrode base 60 and thereby to ensure its alignmentwith various head contours. In certain embodiments, conductive layer 154may be limited in its area and may be configured to cover only a portionof the floor surface of electrode base housing 150. In such a case,conductive layer 154 may not be flexible and may be made of variouselectrically conductive materials known to those of skill in the art.Conductive layer 154 may be configured to be electrically coupled to anelectrical conductor (cable or wire) 158 and thereby be electricallyconnected to the headset electrical circuit.

Electrode pad 56 a may be configured to be releasably coupled(physically and electrically) to electrode base housing 150. Electrodepad 56 a may include at least a portion of water or other liquidabsorbing material such as non-woven fabric, felt or sponge. Whencoupled to housing 150, electrode pad 56 a is configured to be inelectrical contact with conductive layer 154. When the headset isdonned, pad 56 a is urged toward the skin surface and may createelectrical contact with the skin surface (skin surface including thescalp) in order to transfer electrical current to the skin surface.

In some embodiments, the electrode pad 56 a may be provided to the userdry, and the user may soak electrode pad 56 a with water, saline,conductive gel, or any other suitable liquid before use. In otherembodiments, the electrode pad 56 a may be pre-soaked with conductivegel, such that the gel is mostly absorbed in the pad, and the user neednot soak the pad at all. The conductive gel may be any commerciallyavailable conductive gel suitable for use with electrodes. It isappreciated that use of conductive gel improves conductivity and reducesdehydration of the pad 56 a, and that pre-soaked pads 56 a may be easierand less messy for the user to handle.

Electrode pad 56 a and other electrodes associated with the headset maybe configured to receive (sense) electrical current or other bio-signalsfrom the skin surface, such as for example electroencephalogram (EEG)and either transfer it via the headset circuit to an electronic circuitthat includes a microprocessor or transmit it wirelessly to a remoteunit.

Electrode pad 56 a may be disposable and may be conveniently replaced bythe user.

Electrode pad 56 a may be configured to include a peripheral edge 156that is thinner than the central area of pad 56 a. Peripheral edge 156can be made by various manufacturing process such as ultrasonic welding,RF welding or heat compression. By inserting the thin edge 156 into acorresponding groove 152 in housing 150, electrode pad 56 a can bereversibly physically coupled to housing 150 and electrically coupled toconductive layer 154.

Electrode pad 56 a may be configured to have larger area compared tohousing 150. It can therefore be squeezed into housing 150 in order tobe reversibly (physically an electrically) coupled to housing 150.

Electrode base housing 150 may be configured to include a conductingmechanical snap connector configured to be both physically andelectrically reversibly coupled to a corresponding connector attached toelectrode pad 56 a.

Perspective views of an electrode base 60 with and without an inventive,multi-layered electrode pad 56 a are provided in FIG. 15A and FIG. 15B.FIG. 15C and FIG. 15D provide cross-sectional and bottom views ofmulti-layered electrode pad 56 a. Multi-layered electrode pad 56 a mayinclude liquid absorbent layer 254 and a flexible electricallyconductive layer 258, preferably made of a carbon foil. The two layersmay be attached or directly attached. Various manufacturing processesmay be used, including heat welding, RF welding, ultrasonic welding,gluing or sewing. In order to reduce current density at the edges ofliquid absorbing layer 254, conductive layer 258 may be configured tohave a smaller area or “footprint” than layer 254. Consequently, thecurrent density at the edges of layer 254 (which has a lower electricalconductivity with respect to layer 258) will be reduced. Conductivelayer 258 may further include a thin electrically conductive layer 255of conductive paint, which may be printed in a “mesh” pattern and may beconfigured to cover only the central portion of layer 258. Conductivelayer 255 may preferably be printed on the bottom surface of layer 258and may be configured to face conductive layer 154 of electrode basehousing 150 so as to be electrically coupled when multi-layeredelectrode pad 56 a is attached to electrode base housing 150. Conductiveprint layer 255 may be configured to have a higher electricalconductivity compared to layer 258, such that current dispersion overlayer 258 is improved while reducing current density at the edges oflayer 258 (which does not include layer 255).

FIGS. 16A, 17A, 18A, 19A, and 20A provide cross-sectional views of anelectrode base assembly, in which a particular electrode pad structureis coupled to an electrode base housing, according to variousembodiments of the present invention. FIGS. 16B, 17B, 18B, 19B, and 20Bprovide cross-sectional views of each respective electrode pad shown inFIGS. 16A, 17A, 18A, 19A, and 20A.

With reference now to FIGS. 16A and 16B, electrode pad 56 a may includea liquid absorbing layer 254 and a “hook” (e.g., Velcro®) fasteninglayer 252. Both layers may be attached by various manufacturing processsuch as heat welding, RF welding, ultrasonic welding, gluing or sewing.According to one embodiment, electrode base housing 150 may beconfigured to be coupled to a “loop” (e.g., Velcro®) fastening layer256, disposed in a groove in the internal perimeter of elastic housing150. According to one embodiment, in order to releasably coupleelectrode pad 56 a to electrode base housing 150, the user may positionelectrode pad 56 a inside housing 150 and thereby the hook layer 252 ofelectrode pad 56 a and the loop layer 256 may be reversibly attached,ensuring contact between conducting layer 154 and liquid absorbing layer254.

With reference now to FIGS. 17A and 17B, electrode pad 56 a may includethree layers: a liquid absorbing layer 254, a flexible conductive layer258, preferably made of a flexible carbon layer and a “hook” (e.g.,Velcro®) fastening layer 252, coupled to at least portion of the bottomperimeter of electrode pad 56 a. The three layers may be attached byvarious manufacturing process such as heat welding, RF welding,ultrasonic welding, gluing or sewing. According to one embodiment,electrode base housing 150 may be configured to be coupled to a “loop”(e.g., Velcro®) fastening layer 256, disposed in a groove in theinternal perimeter of housing 150. According to one embodiment, in orderto releasably couple electrode pad 56 a to electrode base housing 150,the user may position electrode pad 56 a inside housing 150 and therebyhook layer 252 of electrode pad 56 a and loop layer 256 may bereversibly coupled, ensuring contact between conducting layer 154 ofelectrode base housing 150 and conducting layer 258 of electrode pad 56a.

Conductive layer 258 may be configured to include a layer of conductivepaint that may preferably be printed on its bottom surface configured toface conductive layer 154 of electrode base housing 150. The conductivepaint layer may improve the current distribution across conducting layer258 and liquid absorbing layer 254 and thereby may improve currentdistribution at the contacting skin surface.

Electrode pad 56 a may be configured to include a conducting “male”connector, such as a “male” snap connector, that may be physically andelectrically coupled to electrode pad 56 a and can be reversiblyconnected physically and mechanically to a corresponding “female” snapconnector in electrode base housing 150, which may be electricallycoupled to the headset electrical circuit.

With reference now to FIGS. 18A and 18B, electrode pad 56 a may includethree layers: a liquid absorbing layer 254, a flexible conductive layer258, preferably made of a flexible carbon layer and an adhesive hydrogellayer 302. Liquid absorbing layer 254 and flexible conductive layer 258can be attached by various manufacturing process such as heat welding,RF welding, ultrasonic welding, gluing or sewing. Adhesive hydrogellayer 302 may be adhered to flexible conductive layer 258 by theadhesive properties of the hydrogel layer. According to one embodiment,in order to releasably couple electrode pad 56 a to electrode basehousing 150, the user may position electrode pad 56 a inside housing 150and thereby the adhesive hydrogel layer 302 of electrode pad 56 a andconductive layer 154 may be reversibly coupled, ensuring stable physicaland electrical coupling of electrode base housing 150 and electrode pad56 a.

With reference now to FIGS. 19A and 19B, electrode pad 56 a may beconfigured to include a liquid absorbing layer 254, a flexibleconductive layer 258, (e.g., made of a flexible carbon layer), and adouble adhesive layer 308, coupled to at least portion of the bottomperimeter of electrode pad 56 a which is configured to face conductivelayer 154 of housing 150. Liquid absorbing layer 254 and flexibleconductive layer 258 can be attached by various manufacturing processsuch as heat welding, RF welding, ultrasonic welding, gluing or sewing.Double side adhesive layer 308 may be adhered to flexible conductivelayer 258 by its adhesive properties. According to one embodiment, inorder to releasably couple electrode pad 56 a to electrode base housing150, the user may position electrode pad 56 a inside housing 150 andthereby the double side adhesive layer 308 of electrode pad 56 a andhousing 150 may be reversibly coupled, ensuring stable physical andelectrical coupling of electrode base housing 150 and electrode pad 56a.

With reference now to FIGS. 20A and 20B, electrode pad 56 a may beconfigured to include a liquid absorbing layer 254 and a flexibleconductive layer 258, preferably made of flexible carbon. Liquidabsorbing layer 254 and flexible conductive layer 258 can be attached byvarious manufacturing process such as heat welding, RF welding,ultrasonic welding, gluing or sewing. Electrode pad 56 a may include aperipheral edge 312 that is thinner than the central area of liquidabsorbing layer 254. The thinner edge 312 can be made by certainmanufacturing process such as ultrasonic welding, RF welding or heatcompression. The user can reversibly couple electrode pad 56 a toelectrode base housing 150 by pressing electrode pad 65 a into housing150, until the thinner edge 312 is “snapped” into the correspondinggroove 310 in housing 150. In this position, conductive layer 258 ofelectrode pad 56 a and conductive layer 154 of electrode base housing150 are attached and therefore when the headset is donned, electricalcurrent can be transferred from conductive layer 154 to conductive layer258 and to liquid absorbing layer 254 and then to the skin surface.

FIG. 21 illustrates a perspective view of an electrode base 60.According to certain features of the described preferred embodimentselectrode base 60 may be configured to include at least one springmechanism 320 which may be configured to be physically coupled at oneside to flexible member 80 and at its other side to electrode basehousing 150. Spring mechanism 320 may be configured to provide“self-adjustment” capabilities for electrode base housing 150, so thatwhen the headset is donned, spring mechanism 320 is compressed orexpanded according to the force applied on electrode base housing 150 bythe headset and the counter force applied by the head. In certainembodiments spring mechanism 320 may include an elastic mechanism or asponge instead or in addition to a metal or plastic spring.

FIGS. 21A and 21B provide perspective and cross-sectional views,respectively of an electrode pad 56 a and a bellows-type electrode basehousing 150, according to an embodiment of the present invention.Electrode base housing 150 may be configured to include a flexiblebellows carrier 321 that may be configured to be physically coupled to,or be extended from, the bottom of electrode base housing 150. Flexiblebellows carrier 321 may be configured to provide “self-adjustment”capabilities for electrode base housing 150, such that when the headsetis donned, bellows carrier 321 is compressed or expanded according tothe force applied on electrode base housing 150 by the headset and thecounter force applied by the head.

With reference to FIG. 21B, flexible bellows carrier 321 may beconfigured to have the following dimensions:

A—The height of each crease of the bellows. A may be within a range of 1mm-8 mm, 2 mm-6 mm, or 2 mm-4 mm;B—The angle of each crease of the bellows. B may be within a range of40°-90°, 50°-80°, or 60°-80°;C—The thickness of the wall of the bellows. C may be within a range of0.3 mm-3 mm, 0.4 mm-2 mm, or 0.5 mm-1.5 mm.

FIGS. 21C and 21D provide perspective and cross-sectional views,respectively of an electrode pad 56 a and electrode base housing 150having a conical shaped bellows carrier 321, according to embodiments ofthe present invention. Conical shaped flexible bellows carrier 321 maybe configured to be physically coupled to, or extended from, the bottomof electrode base housing 150. Bellows carrier 321 may be configured toprovide “self-adjustment” capabilities for electrode base housing 150,such that when the headset is donned, bellows carrier 321 may becompressed or expanded according to the force applied on electrode basehousing 150 by the headset and the counter force applied by the head.Bellows carrier 321 may be configured to reversibly and repeatedlycollapse to less than 50%, less than 40%, less than 30%, or less than20% of its initial, relaxed height. This may enable appreciably improvedalignment of the headset and electrode pad 56 a against the head.

FIG. 22 is a perspective view of electrode base housing 150. Accordingto one embodiment, electrode base housing 150 is configured to include acircumferential sealing rim 360. Stimulation in the presence of hair,such as when attempting to non-invasively stimulate various areas of thehead, presents a challenge, since the hair creates a high impedancelayer between the superficial electrodes and the skin. Solid adhesivehydrogel is the most common conductive medium used in electricalstimulation electrodes. However, hydrogel may not be particularlysuitable for use in the presence of hair, due to poor penetration of thehair layer.

Tap water may be suitable from a penetration standpoint, since it canpass through the hair layers and does not leave residue, and is commonlyavailable. The inventors have found that in order to ensure the requiredconductivity and substantially even current distribution, a substantiallayer of water should be maintained against the scalp during thetreatment and dehydration should be prevented, especially duringprolonged treatment sessions. Prevention of electrode dehydration mayalso be required in areas that do not include hair, such as theforehead.

However, in some embodiments, the electrode pad 56 a may be pre-soakedwith a conductive gel, thus allowing for better conductivity andstimulation and reduced dehydration than those achieved with water. Thisembodiment is advantageous in that it maintains user-friendliness inthat the user need not apply the gel to the pad himself, and in that thegel is mostly contained within the pad, such that excess amounts of gelsubstantially do not spread over and out of the stimulation area. Asmentioned above, the conductive gel may be any commercially availableconductive gel suitable for use with electrodes.

FIG. 23 provides a cross-sectional view of electrode base housing 150with electrode pad 56 a inserted.

FIG. 24 is a cross-sectional view of electrode base housing 150 withelectrode pad 56 a inserted, while urged against a skin surface 362. Thehousing 150 may be adapted such that a pressure exerted againstelectrode base 60 (not shown) perpendicularly to the sealing rim 360 andtowards a skin surface 362 of a user, urges sealing rim 360 against theskin surface to substantially seal the cavity created between sealingrim 360 and the skin surface 362 of the user and an ambient or externalenvironment.

Sealing rim 360 may be made of flexible material such as TPU or silicon,and may be configured to have a modulus of elasticity that is sufficientto maintain a level of pressure against the scalp that provides therequired sealing effect. However, an overly large modulus of elasticitymay result in excessive pressure against the scalp. Sealing rim 360 maybe sufficiently pliant to be self-aligning to various head contours.Sealing rim 360 may be configured to have a high drag coefficient, inorder to assist in stabilizing the electrode in place against the scalp.Also, sealing rim 360 may be configured to prevent dehydration of thewetted pad and the liquid contained within the sealed space and therebyto enable effective and prolonged sessions of stimulation. Sealing rim360 may be configured to be detachable from the electrode base when thestimulation electrode is placed in areas where sealing is not needed.

The headset may be configured to include sealing rims having variouscontours, to ensure proper sealing functionality at specific skinsurfaces and locations. In order to reach the required sealing effect,sealing rim 360 may be configured to include material that inflates inthe presence of liquid such as water.

Electrode base housing 150 with sealing rim 360 may be configured to beused in areas that do not include hair such as the forehead or otherareas of the body, for example, in order to prevent electrode paddehydration.

Electrode base housing 150 with sealing rim 360 may be configured toinclude the following dimensions (see FIG. 25):

The inner surface of the flexible circumferential wall of housing 150has a radial curvature, wherein a radial distance (A) between an innersurface of rim 360 and a most radially inward point of the inner surfaceof the wall of housing 150, is in the range of 1 to 15 mm, 2 mm to 10mm, or 2 mm to 7 mm.

The outer surface of the flexible circumferential wall of housing 150has a radial curvature, wherein the length (B) of the curvature iswithin a range of 1 mm to 15 mm, 2 mm to 10 mm, or 2 mm to 8 mm.

FIG. 25A provides a cross-sectional view of an inventive electrode basehousing 150 having a sealing rim 360 and containing an electrode pad 56a, the electrode pad being urged against a skin surface 362. The housing150 may be adapted such that a pressure exerted against electrode base60 (not shown) perpendicularly to the sealing rim 360 and towards a skinsurface 362 of a user, urges sealing rim 360 against the skin surface tosubstantially seal the cavity created between sealing rim 360 and theskin surface 362 of the user and an ambient or external environment.

Sealing rim 360 may be made of flexible material such as TPU or silicon,and may be configured to have a modulus of elasticity that is sufficientto maintain a level of pressure against the scalp that provides therequired sealing effect. However, an overly large modulus of elasticitymay result in excessive pressure against the scalp.

According to certain embodiment the level of hardness of sealing rim 360may be 20-50 Shore A, more preferably 20-40 Shore A, most preferably30-40 Shore A.

According to certain embodiment the modulus of elasticity (E) of sealingrim 360 (at 100% strain) is 0.4 MPa-3 MPa, 0.5 MPa-2 MPa, or 0.5 MPa-1.2MPa.

Sealing rim 360 may be configured to prevent dehydration of the wettedpad and the liquid contained within the sealed space and thereby toenable effective and prolonged sessions of stimulation.

FIG. 25B provides a cross-sectional view of the housing 150, sealing rim360 and pad 56 a arrangement of FIG. 25A in a relaxed mode, and in whichthe wall geometry is defined. Electrode base housing 150 with sealingrim 360 may be configured to have the following dimensions (see FIG.25B):

Sealing rim wall thickness (A) may be 0.3 mm-3.0 mm, 0.4 mm-1.5 mm, or0.5 mm-1 mm.

Sealing rim curvature length (B) may be 1 mm-10 mm, 2 mm-8 mm, or 3 mm-6mm.

Sealing rim curvature height (C) may be 1 mm-10 mm, 2 mm-8 mm, or 2 mm-4mm.

FIG. 25C provides a perspective view of an inventive electrode basehousing 150 containing an electrode pad 56 a, the housing containing aplurality of closely spaced sealing fingers 361 circumferentiallyenveloping the electrode pad 56 a. Housing 150 may be adapted such thata pressure exerted against electrode base 60 (not shown) perpendicularlyto the sealing fingers 361 and towards a skin surface of a user, urgessealing fingers 361 against the skin surface to at least partially seal,or at least substantially seal, the cavity created between sealingfingers 361 and the skin surface of the user and an ambient or externalenvironment.

Sealing fingers 361 may be made of flexible material such as TPU orsilicon, and may be configured to have a modulus of elasticity that issufficient to maintain a level of pressure against the scalp thatprovides the required sealing effect.

According to certain embodiment, sealing “fingers” 361 are configured toself-align to various surface/skin contours. The fluid surface tensionprevents it from flowing between fingers 361 and thereby the fluid iskept around pad 56 a.

FIG. 25D provides a cross-sectional view of the arrangement of FIG. 25C.

FIG. 25E provides a top view of the arrangement of FIG. 25C. Electrodebase housing 150 with sealing fingers 361 may be configured to includethe following dimensions (see FIGS. 25D and 25E):

The thickness (A) of a sealing finger 361 is preferably 0.3 mm-1.5 mm,more preferably 0.4 mm-1.2 mm, most preferably 0.5 mm-1 mm.

The angle (B) of a sealing finger 361 is preferably 20°-90°, morepreferably 40°-80°, most preferably 60°-80°.

The width (C) of a sealing finger 361 is preferably 0.3 mm-3 mm, morepreferably 0.4 mm-2.5 mm, most preferably 0.5 mm-1.5 mm.

The gap (D) between sealing fingers 361 is preferably 0.1 mm-1.5 mm,more preferably 0.2 mm-0.1 mm, most preferably 0.2 mm-0.8 mm.

FIG. 25F provides a cross-sectional view of an inventive housing 150 andpad 56 a arrangement in which a wall curvature 363 of housing 150 isadapted to trap and store excess fluid in the cavity 366 created betweenthe inner wall curvature and pad 56 a. When the headset is donned, pad56 a is urged against the head and may release some of its excess fluidinto cavity 366. The fluid contained in cavity 366 may later bereabsorbed by pad 56 a and released toward the skin surface.

FIG. 25G provides a schematic perspective cross-sectional view of oneembodiment of the inventive electrode base housings 150 positioned on ahead 5 of a user and urged against the head, and FIG. 25H providesmagnified views of the electrode base housings 150 and sealing rims 360urged against head 5.

FIG. 26 is a perspective view of a flexible, comb-like (“hair clearing”)member 376 disposed above an electrode base housing, according toembodiments of the invention. Member 376 may be configured to bephysically coupled to the headset above electrode base housing 150, andmay be configured to include several elongated rigid and preferablysemi-rigid members or teeth 378.

FIG. 27 is a perspective rear view of a donned headset in which theflexible, comb-like member 376 protrudes above the circumferential bandof headset 10. While the user dons headset 10 on his head 372, elongatedmembers 378 may be configured to jut above the electrodes at areas thatinclude hair, such as the back or sides of the head. Comb-like member376 may be configured to enable simple donning of headset 10 whileensuring temporarily pushing away and clearing of hair layers under theelectrodes so that only minimal amount of hair will remain between theelectrodes and the skin. Flexible, comb-like member 376 may beconfigured to function like a comb, separating layers of hair 374 fromthe scalp while headset 10 with its electrodes is pushed upward by theuser into an operating position on head 372, thereby ensuring therequired electrical conductivity between the electrodes and the skin.

According to another features of the described preferred embodiments,member 376 may be configured to be detachable from headset 10 in orderto enable its removal by the user, for example, in the case that theuser has short hair.

The invented headset is configured to stimulate various areas of thehead by electrodes in various shapes and sizes. The headset may includeelectrodes configured to stimulate the forehead region.

FIG. 28 is a perspective anterior view of a donned headset 10, theheadset configured, and the front electrodes 110 a and 110 b adapted andpositioned, to stimulate specific nerve branches in the forehead region.These specific nerve branches include the supratrochlear 120 a, 120 band supraorbital 122 a, 122 b nerves, both of which are superficialbranches of the trigeminal nerve. Electrodes 122 a and 122 b may beconfigured to have a narrow elongated contour and to be at leastpartially aligned with the contour of the eyebrows 112 a and 112 b inorder to achieve the desired nerve depolarization with minimalstimulation intensity and sufficient level of sensory comfort.Electrodes 110 a and 110 b may be configured to have a minimal size anda particular shape, in order to minimize unpleasant sensation that maybe elicited when pain nerve fibers disposed on the periosteum of theskull bone are activated. Electrodes 110 a and 110 b may be alsoconfigured to ensure proper stimulation of the target nerves despite thewide range of morphological variables in the target population. Anadditional consideration that may influence the dimensions of theelectrode and specifically its length, is an expected deviation that mayoccur in the rotational placement of headset 10, when donned by theuser. Therefore, the electrodes may preferably be configured to havesufficient length to ensure placement of at least part of the electrodeabove the target nerves, even when such rotational deviation occurs.

FIG. 29 is an illustration of an embodiment of electrode 110 a whichelectrode may be configured for stimulation of the supraorbital region.Electrode 110 a may include a biocompatible conducting materialconfigured to face the skin surface, and may be configured to include anelectrode backing attached to a conductive contact surface. The backingmay contain at least one conductive material or element that may beelectrically coupled with the conductive contact surface.

Electrode 110 a may be configured to have a conductive contact surfacewith the following dimensions:

(i) a long dimension (D_(L)) having a length of 20 mm to 55 mm, 25 to 50mm, or 30 to 45 mm.(ii) a narrow dimension (D_(N)) having a length of 10 mm to 30 mm, 10 to25, or 12 to 20 mm.Concave contour E has a concavity defined by boundary points G and F,which points are disposed at opposite ends of the concavity.

Typically, A/L is at least 0.5 mm,

A being an area bounded by dotted line K and the concavity;L being a length of line K (between boundary points G and F), (L) beingat least 10 mm, wherein a line disposed between a first point on theconcave contour and a second point on the perimeter of electrode 110 a,on a side opposite to concave contour E, and aligned in perpendicularfashion with respect to contour E at the first point, has a length H,and wherein, over an entirety of the concave contour,

H _(max) /H _(min)≦2.5

H_(max) being a maximum value of H over this entirety; andH_(min) being a minimum value of H over this entirety.

The distance between two electrodes configured to stimulate thesupraorbital region may be in a range of 5-45 mm, 8-35 mm, or 8-25 mm.Additional electrodes may be located on the headset in order tostimulate other nerves, for example, the zygomaticotemporal nerve or theauriculotemporal nerve. The headset may also include electrodes that areconfigured to stimulate the occiput region.

FIG. 30 provides an embodiment in which electrodes 146 a and 146 b areconfigured to be located at the rear aspect (facing the occiput) ofheadset 10 in order to stimulate nerves at the occiput region 140, suchas the left side greater occipital nerve 142 a and the right sidegreater occipital nerve 142 b. Additional electrodes may be located inthe headset and configured to stimulate other nerves in the head region,such as left and right lesser occipital nerves 143 a and 143 b.

In order to stimulate the branches 142 a and 142 b of the greateroccipital nerve, the electrodes may be configured to be positioned abovethe nerve branches at approximately the level of the occipitalprotuberance, where the branches of the greater occipital nerve becomesuperficial after piercing the trapezius fascia. Stimulation below thisanatomical area may cause disadvantageous contraction of the upper neckmuscles while stimulation at a higher area may cause disadvantageouscontraction of the scapularis muscle and may cause painful sensation dueto proximity to the nociceptive nerve fibers of the skull periosteum. Itis therefore important to ensure that stimulation performed withaccurate placement of the electrodes and with electrodes that haveappropriate dimensions that ensure effective stimulation with high levelof sensory comfort and without overflow of the stimulation to nearbymuscles. In some embodiments, the dimensions of electrodes 146 a and 146b are preferably in the range of 20-50 mm in length and 8-40 mm inheight; electrodes 146 a and 146 b may be disposed at a distance of 5-35mm from the occiput midline. More typically, electrodes 146 a and 146 bhave a length within a range of 25-45 mm and a height within a range of10-25 mm; electrodes 146 a and 146 b may be disposed at a distance of8-25 mm from the occiput midline.

FIG. 31 illustrates a side perspective view of bilateral member 50 awhich, according to one embodiment, is part of the inventive headset.According to certain features of the described preferred embodiments,member 50 a is configured to be rigid and preferably semi-rigid, havinga curved portion 408 adapted to align behind and above the ear.

FIG. 32 illustrates a perspective view of headset 10 on head 500.Headset 10 may be configured to enable accurate placement on the head ina way that may be both repeatable and intuitive for a user withoutclinical expertise. Precise electrode placement over the targetperipheral nerves and brain areas is essential in order to achieve thedesired therapeutic benefits. When stimulating the head region, accurateelectrode placement is especially important, since even slight deviationin the electrode position may elicit unpleasant sensation and even pain,due to stimulation over the periosteum of the skull bone, or may causeunwanted motor contraction of muscles such as the frontalis, temporalis,scapularis or the upper neck muscles.

Bilateral rigid and preferably semi-rigid member 50 a may be configuredto enable the user to position headset 10 on his head 500 in asubstantially accurate and repeatable manner. When curved bilateralmember 50 a is positioned behind and above both ears, both thecircumferential (rotational) and longitudinal placement of headset 10are determined with respect to head 500.

Headset 10 may be configured to include a recess 410 at its anteriorportion, configured to be aligned with the glabella midline and above anose bridge 506. In order to ensure proper circumferential (rotational)and longitudinal placement of headset 10 with respect to head 500without the need to use a mirror, the user may position his thumb onnose bridge 506 and one of his fingers (of the same hand) on recess 410,to ensure that headset 10 is accurately positioned.

The contour of frontal elastic member 40 of headset 10 may be configuredto align with the anatomical lines of eyebrows 502 and an upper area ofnose bridge 506, such that when it is aligned by the user above theeyebrows, the headset rotational and longitudinal orientation isdetermined.

In order to suit each particular user, the rotational position of thebilateral semi-rigid members 50 a, relative to headset 10, may beindividually adjusted; semi-rigid members 50 a of different size andshape may be selected in order to optimally adjust the orientation ofheadset 10; frontal elastic member 40 of various contours may beselected in order to adjust the anterior longitudinal orientation of theheadset; and the position of recess 410 may be adjusted or headset 10and its integrated electrodes may be configured for a non-symmetricalalignment, as necessary.

Posterior elastic member 30 of headset 10 may be configured to have aconcave shape that may be aligned above the occipital protrusion and thenuchal line, thereby the longitudinal placement of headset 10, and morespecifically, the longitudinal placement of posterior elastic member,may be determined.

FIG. 33 is a perspective anterior view of headset 10 with a “nosebridge” member 510. “Nose bridge” member 510 may be configured to belocated in the central area of elastic member 40. “Nose bridge” member510 may be rigid or semi-rigid, and may have two elongated portionsadapted to be aligned at both sides of the upper part of the nose andthe nose bridge. Positioning the “nose bridge” member over the nose mayallow the user to determine headset 10 rotational and longitudinalplacement.

The “nose bridge” member 510 may also be configured to further supportmember 40 against gravity. “Nose bridge” member 510 may be configured tobe detachable from headset 10. A “nose bridge” member 510 of varioussizes and shapes may be selected for individual users. “Nose bridge”member 510 may be configured to be manually adjusted by the user foroptimal adjustment to the nose of the user.

FIG. 34 is a perspective view of headset 10 having eyeglasses 520.Eyeglasses 520 may be adapted to be coupled to frontal elastic member40. In some embodiments, eyeglasses 520 may be configured to:

-   -   be reversibly and repeatedly detachable from headset 10;    -   include various lenses such as optical lenses for improved        eyesight, sunglasses, or non-optical transparent lenses;    -   include highly dark lenses that may be used to block external        light, for example, in order to assist during migraine attack or        for relaxation.

FIG. 35 is a perspective view illustration of headset 10 havingearphones such as bilateral earphones 522. In some embodiments,bilateral earphones 522 may be configured to be electrically connectedto an at least semi-rigid bilateral member 50 a.

In some embodiments, earphones 522 and bilateral member 50 a may beconfigured such that earphones 522 are reversibly and repeatedlydetachable from bilateral member 50 a.

In some embodiments, bilateral member 50 may be adapted to include aninternal space and an opening that may be served for storage ofearphones 522 when earphones 522 are not in use. Bilateral member 50 mayinclude a mechanism that pulls earphones 522 into a storage space withinbilateral member 50 a, when earphones 522 are not in use.

FIG. 36 illustrates a perspective view of headset 10 along with a remotecontrol or remote control handset 560, a mobile phone 570 and alaptop/PC 580.

In some embodiments, headset 10 may be configured to communicatewirelessly with remote control 560. Remote control 560 may be used bythe user to send commands to headset 10, such as stimulation initiationor cessation commands, or commands to increase or decrease thestimulation intensity. Remote control 560 may also present variousvisual and audio indications for the user regarding the status ofheadset 10.

Headset 10 may be configured to wirelessly communicate with a mobilephone 570. The mobile phone interface may be used to present variousdata sent wirelessly by headset 10, for example, visual and audioindications regarding the status of headset 10 and usage logs.

Headset 10 may be configured to wirelessly communicate with laptop/PC580. The mobile phone interface may be used to present various data sentwirelessly by headset 10, such as visual and audio indications regardingthe status of headset 10 and usage logs.

Communication between headset 10 and remote control 560, mobile phone570 and laptop 580 may be performed in various ways, known to those ofordinary skill in the art, for example by Bluetooth communication.

As used herein in the specification and in the claims section thatfollows, the term “monolithic” means structurally behaving as a single,at least semi-rigid whole.

As used herein in the specification and in the claims section thatfollows, the term “monolithically donnable”, with respect to a headset,headset frame, or the like, refers to a structure enabling the donningof the headset, headset frame, or the like as a single, at leastsemi-rigid whole.

As used herein in the specification and in the claims section thatfollows, the term “operational mode”, or the like, with respect to aheadset or headset component, refers to a headset or headset componentthat is fitted onto the head of the user, in a suitable rotational andlongitudinal disposition, with electrical stimulation being applied.

As used herein in the specification and in the claims section thatfollows, the term “donned mode”, “donned”, or the like, with respect toa headset or headset component, refers to a headset or headset componentthat is fitted onto the head of the user, in a suitable rotational andlongitudinal disposition, with electrical stimulation being applied.

As used herein in the specification and in the claims section thatfollows, the term “integral” refers to a structure behaving as a single,whole structure. The term may be applied in particular to flexiblestructures such as an electrode pad.

As used herein in the specification and in the claims section thatfollows, the term “liquid” refers to a liquid such as water, saline, ora conductive gel.

It will be appreciated that certain features of the invention, whichare, for clarity, described in the context of separate embodiments, mayalso be provided in combination in a single embodiment. Conversely,various features of the invention, which are, for brevity, described inthe context of a single embodiment, may also be provided separately orin any suitable sub-combination. Similarly, the content of a claimdepending from one or more particular claims may generally depend fromthe other, unspecified claims, or be combined with the content thereof,absent any specific, manifest incompatibility therebetween.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

What is claimed is:
 1. A headset for use in delivering electricalstimulation to a skin surface of a head of a user, the headsetcomprising: (a) a circumferential headset body, said body having amonolithic frame adapted to circumferentially fit around the head of theuser, said body housing an electric circuit adapted to be connected to apower source; said headset body including an elastic arrangement,disposed on at least a portion of a circumference of said headset body;said elastic arrangement adapted to be tensioned along saidcircumference; (b) at least one electrode base, mechanically and atleast semi-rigidly connected to said headset body, and electricallyassociated with said electric circuit, said electrode base adapted toreceive at least one electrode pad; said headset body and said baseadapted to orient an electrical stimulation surface of said pad towardsthe skin surface, during donning by the user; said elastic arrangementadapted such that, during said donning, said elastic arrangementradially urges said electrode base towards the skin surface such thatsaid electrode pad makes physical and electrical contact with the skinsurface; said elastic arrangement and said electrode base adapted suchthat for various degrees of tensioning of said elastic arrangement, acircumferential position of said electrode base, with respect to saidframe, is fixed in a unique position.
 2. The headset of claim 1, saidcircumferential headset body having a front section adapted to fitaround a front portion of the head, said at least one of said at leastone electrode base being a front electrode base disposed on said frontportion.
 3. The headset of claim 2, said front section being a frontmechanical element that is physically distinct from said circumferentialheadset body.
 4. The headset of claim 3, said front mechanical elementspanning at most 40% of a circumference of said circumferential headsetbody.
 5. The headset of claim 1, said circumferential headset bodyhaving a rear section adapted to fit around a rear portion of the head,at least one of said at least one electrode base being a rear electrodebase disposed on said rear portion.
 6. The headset of claim 5, said rearsection being a rear mechanical element that is physically distinct fromsaid circumferential headset body.
 7. The headset of claim 6, said rearmechanical element spanning at most 40% of a circumference of saidcircumferential headset body.
 8. The headset of claim 1, said frameincluding at least semi-rigid side components, bi-laterally disposed onsaid frame, and forming side portions of said circumference of saidheadset body.
 9. The headset of claim 1, said frame including apositioning system for angular and longitudinal positioning of saidheadset body, said positioning system including at least one at leastsemi-rigid side component, said side component having: (i) a first,elongated element, forming a portion of said circumference, and adaptedto fit above an ear of the user, to determine said longitudinalpositioning, and (ii) a second element disposed generally perpendicularto said elongated element, and adapted to fit behind said ear, todetermine said angular positioning of said headset body.
 10. The headsetof claim 1, said frame including at least a first bi-lateral sizeadjustment mechanism adapted to fixedly adjust said circumference ofsaid headset body.
 11. The headset of claim 1, said headset body adaptedto juxtapose a contact surface of an electrical device opposite oragainst the skin surface, said elastic arrangement adapted to radiallyurge said electrical device towards said skin surface such that acontact surface of said electrical device makes physical contact withsaid skin surface; said elastic arrangement adapted such that forvarious degrees of tensioning of said elastic arrangement, acircumferential position of said electrical device is fixed in a uniqueposition.
 12. The headset of claim 11, said electrical device includinga sensor adapted to sense a body parameter associated with the head ofthe user.
 13. The headset of claim 1, further comprising said at leastone electrode pad, said pad including: (a) a liquid-absorbent layerhaving a biocompatible contact surface, said contact surface adapted tobe juxtaposed against the skin surface; (b) an electrode backing,attached to said liquid-absorbent layer, said backing containing atleast one electrically conductive material or element, said conductivematerial or element being electrically connected with saidliquid-absorbent layer, when said liquid-absorbent layer is filled withliquid; said biocompatible contact surface having: (i) a long dimension(D_(L)) having a maximum length of 20 mm to 55 mm; (ii) a narrowdimension (D_(N)) having a maximum length of 10 mm to 25 mm; wherein afirst side of a perimeter of said biocompatible contact surface has agenerally concave contour having a concavity defined by first and secondboundary points disposed at opposite ends of said concavity, wherein:A/L≧0.5 mm A being an area bounded by said line and said concavity; Lbeing a length of a line between said boundary points; said length (L)being at least 10 mm; wherein a line disposed between a first point onsaid concave contour and a second point on said perimeter, on a sideopposite said concave contour, and aligned in perpendicular fashion withrespect to said contour at said first point, has a length H, andwherein, over an entirety of said concave contour,H _(max) /H _(min)≦2.5, H_(max) being a maximum value of H over saidentirety; and H_(min) being a minimum value of H over said entirety. 14.The headset of claim 1, said at least one electrode pad including: (a) aliquid-absorbent layer having a biocompatible, conductive contactsurface, said contact surface adapted to be juxtaposed against the skinsurface; (b) an electrically conductive layer having a broad first facejuxtaposed against, or attached to, said liquid-absorbent layer, saidconductive layer containing at least one electrically conductivematerial or element, said conductive layer adapted to transfer anelectrical current from a broad second face, distal to said first face,to said liquid-absorbent layer, via said first face.
 15. The headset ofclaim 14, said liquid-absorbent layer including at least one materialselected from the group consisting of a non-woven fabric, felt orsponge.
 16. The headset of claim 14, said electrically conductive layerhaving, on said second face, a layer of electrically conductive paint,preferably disposed in a mesh pattern.
 17. The headset of claim 14, saidelectrically conductive layer containing a carbon foil.
 18. The headsetof claim 17, said carbon foil having a resistivity within a range of1-180 ohm/square or 30-100 ohm/square.
 19. The headset of claim 16, saidliquid-absorbent layer and said electrically conductive layer havingsaid layer of electrically conductive paint forming an integralstructure.
 20. The headset of claim 1, said electrode base having: (a) ahousing including a floor, and a flexible circumferential membersurrounding said floor, and having a flexible circumferential wallextending generally above a perimeter of said floor, said wall ending ina circumferential rim; said floor and said flexible circumferentialmember forming a cavity adapted to receive an electrically conductiveelectrode pad; and (b) an electrically conductive material, disposed atleast partially above, or within, said floor; said conductive layeradapted to be electrically associated to an electrical circuit, by meansof an electrical conductor, and, when said pad is inserted, toelectrically communicate with said electrode pad; said rim and saidflexible circumferential wall adapted such that a pressure exertedagainst said electrode base, generally perpendicular to said rim, andtowards a skin surface of a user, urges said rim against said skinsurface, to substantially fluidly seal between said cavity and anambient or external environment.